Kornimate/medical-research-clean huggingface dataset:
validation and optimization of the individual benefits of locating systems in dementia care

Conditions: Dementia

Summary: the project aims to make new technologies for locating people with dementia easier to use for the patients and those caring for them. objective: to systematically understand what improves the user experience of persons with dementia (pwd) and their primary caregivers (cg) with locating system watches to ultimately allow users to obtain more benefits from using these watches. aim: improving the user experience of pwd and cg with locating system watches using a cross-over design and a theory-based educational session approach.

this entire research field (assistive technology in dementia care) is based on the need to address care solutions for a growing number of pwd and cg in the absence of a cure for (alzheimer's) dementia. methods: a user study with two free available locating watches. in educational sessions pwd obtain a locating watch and their cg a smartphone with the application of the locating watch installed on it. by using a cross-over design each dyad (pwd and cg) obtaining both locating systems. the designed educational session hopefully ease subsequent use and make it more enjoyable. the dyads will use each system over four weeks in their real environment.

Eligibility criteria:
inclusion criteria: * diagnosis of all kinds of dementia or mild cognitive impairment exclusion criteria: * not able to move outside alone

Keywords: assistive technology dementia care tracking technology locating systems user experience
a study to compare subcutaneous (sc) versus intravenous (iv) administration of herceptin (trastuzumab) in women with human epidermal growth factor receptor (her) 2-positive early breast cancer

Conditions: Breast Cancer

Summary: in this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide) concurrent with either sc herceptin or iv herceptin. after surgery, participants will receive a further 10 cycles of sc or iv herceptin as per randomization to complete 1 year of treatment. all cycles will be 21 days in length. after the end of study treatment, participants will be followed for safety and efficacy for up to 5 years or until disease recurrence, whichever is earlier.


Eligibility criteria:
inclusion criteria: * adult women greater than or equal to (≥) 18 years of age * non-metastatic primary invasive adenocarcinoma of the breast clinical stage i to iiic, including inflammatory and multicentric/multifocal breast cancer, with tumor size ≥1 centimeter (cm) by ultrasound or ≥2 cm by palpation, centrally confirmed her2-positive (immunohistochemical score \[ihc\] 3+ or in situ hybridization \[ish\]-positive) * at least 1 measurable lesion in breast or lymph nodes (≥1 cm by ultrasound or ≥2 cm by palpation), except for inflammatory carcinoma (t4d) * baseline left ventricular ejection fraction (lvef) ≥55% * eastern cooperative oncology group (ecog) status of 0 or 1 * adequate organ function at baseline exclusion criteria: * history of any prior (ipsilateral and/or contralateral) invasive breast carcinoma * past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix * metastatic disease * any prior therapy with anthracyclines * prior anti-her2 therapy or biologic or immunotherapy * serious cardiac illness * pregnant or lactating women
early mobilization of ischemic stroke patients within 24-hours after intravenous-tissue plasminogen activator (iv-tpa)

Conditions: Ischemic Stroke

Summary: the purpose of this study is to study the safety and feasibility of mobilization of acute ischemic stroke patients treated with iv-tpa between 12-24 hours of treatment.

abstract: introduction historical precedence exists demonstrating that early intensive care unit (icu) mobilization of patients reduces risks of complication and lengths of hospital stay, and may improve long-term health status of patients. objective to determine the safety of early mobilization by physical and/or occupational therapy in acute ischemic stroke patients within 24-hours of iv-tpa infusion and to examine if early mobilization leads to shortened icu and hospital length of stay. methods prospective study of incidence of adverse response and functional mobility status of study patients mobilized by occupational and/or physical therapy between 12- 24 hours after iv-tpa infusion with comparison of icu and hospital length of stay data between study group and pre-study patients who were mobilized by occupational and/or physical therapy services at no pre-determined time after iv-tpa infusion. additionally, patients will be contacted by study personnel approximately 3 to 5-days and 30-days post-infusion for completion of modified rankin scale stroke disability survey as follow up of stroke recovery. setting medical and surgical intensive care units at mayo clinic florida. patients all patients with acute ischemic stroke who receive intravenous tissue plasminogen activator (iv-tpa) infusion, survive to discharge from the hospital, are hemodynamically stable, and are mobilized by physical and/or occupational therapy within 24 hours post-tpa infusion.

Eligibility criteria:
inclusion criteria: * patients post acute ischemic stroke that have been treated with intravenous tissue plasminogen activator (iv-tpa) * 13 hours have elapsed since initiation of intravenous tpa infusion * patients are hemodynamically stable (e.g., not on vasopressors or antihypertensive drips or requiring multiple iv prn boluses of either medication) * patient is able to actively engage in the evaluation exclusion criteria: * patients with femoral sheaths or recent removal of femoral sheaths * patients who are hemodynamically unstable, with active bleeding from lines, catheters, int site or wounds or angioedema * electrocardiogram showing (hr\>100) * vital signs (hr \> 100, sbp \ 180, dbp \ 105) * patients experiencing marked diaphoresis, facial pallor, intense anxious or painful facial expression (especially in aphasic patients)

Keywords: ischemic stroke tissue plasminogen activator early mobilization patient safety length of stay
toripalimab and js004 combined with platinum-based chemotherapy for relapsed and extensive-stage small cell lung cancer

Conditions: Small Cell Lung Cancer Extensive Stage; Small Cell Lung Cancer Recurrent

Summary: for extensive-stage small cell lung cancer (sclc), platinum-chemotherapy (cisplatin or carboplatin) combined with etoposide as the first-line treatment is recommended. however, the recurrence rate is extremely high after the initial first-line treatment. for those who relapse or progress within more than six minths after the end of the-first-line treatment, chose the current guideline recommendation trearment plan has the poor prognosis. a new immunotherapeutic strategy is needed to achieve better anti-tumor effects. js004 is a new antibody targeting b and t lymphocyte attenuator (btla), which restrains immune cells; function and leads to immune escape of tumor cells. the combination of pd-1 and btla antibodies has shown a good therapeutic effect in solid tumors. this trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and js004 combined with platinum-based doublet chemotherapy in extensive-stage sclc or relapsed within more than six months after radical treatment sclc.


Eligibility criteria:
inclusion criteria: 1. the patient shall sign the informed consent form; 2. aged 18 ≥ years; 3. histological or cytological diagnosis of sclc by needle biopsy or ebus, and extensive stage or recurrent confirmed by imageological examinations or relapsed within more than six months after radical treatment sclc; 4. eastern cooperative oncology group (ecog) performance-status score of 0 or 1; 5. life expectancy is at least 12 weeks; 6. at least 1 measurable lesion according to recist 1.1; 7. patients with good function of other main organs (liver, kidney, blood system, etc.); 8. fertile female patients must voluntarily use effective contraceptives from the start of the trial to within 30 days after its completion, and urine or serum pregnancy test results within 7 days prior to enrollment are negative; 9. unsterilized male patients must voluntarily use effective contraception during the trial period and for 30 days after its conclusion. exclusion criteria: 1. patients with a malignancy other than sclc within five years prior to the start of this trial; 2. participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.); 3. with activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment; 4. participants who are allergic to the test drug or any auxiliary materials; 5. participants with active hepatitis b, hepatitis c or hiv; 6. participants with interstitial lung disease currently; 7. pregnant or lactating women; 8. any malabsorption; 9. participants suffering from nervous system diseases or mental diseases that cannot cooperate; 10. other factors that researchers think it is not suitable for enrollment.

Keywords: small cell lung cancer toripalimab js004 extensive-stage recurrent
bevacizumab versus cidofovir for the treatment of recurrent respiratory papillomatosis

Conditions: Recurrent Respiratory Papillomatosis

Summary: the aim of this study is to compare the efficacy of intralesional bevacizumab, a monoclonal antibody against vascular endothelial growth factor, versus the antiviral drug cidofovir in patients with recurrent respiratory papillomatosis.

the investigators designed a randomized, double-blind, placebo-controlled study. children and adults will be randomized to receive either 3 dosis of intralesional bevacizumab, cidofovir or saline solution. primary endpoints are the assessment of changes in the annual surgery rate and derkay papilloma severity grading scale; secondary endpoints are changes in the voice handicap index and safety.

Eligibility criteria:
inclusion criteria: * patients diagnosed with recurrent respiratory papillomatosis proven by biopsy. * patients with 2 or more previous surgeries for papillomatosis exclusion criteria: * patients with heart or renal disease * patients who receive another adjuvant therapy

Keywords: laryngeal papillomatosis cidofovir bevacizumab recurrent respiratory papillomatosis
neuroinflammation in hypertension study

Conditions: Resistant Hypertension

Summary: to demonstrate that in patients with resistant hypertension oral treatment with minocycline via inhibition of central immune cell activation and inflammation results in reduced central sympathetic outflow and concomitant lowering of bp.

this is a randomized, double-blind, placebo controlled, parallel group design study aiming to compare the effects of minocycline 100mg twice daily vs matched placebo for 12 weeks on ambulatory bp and the parameters of sympathetic and immune activation

Eligibility criteria:
inclusion criteria: * aged: 45 -65 years * signed informed consent * clinical diagnosis of resistant hypertension * daytime systolic ambulatory bp \>135mmhg. exclusion criteria:• egfr of \<45 ml/min/1.73m2 * history of myocardial infarction (mi) or any cardiovascular event within 3 months of screening period, clinically significant av conduction disturbances and/or arrhythmias, * current of past history of heart failure (lvef ≤40%) * psychotropic agents, antidepressants and nsaids * alcohol consumption of \>3 standard drinks. * known hypersensitivity or contraindication to minocycline or other tetracyclines.
pharmacokinetics, pharmacodynamics and safety evaluation of sar279356 in intensive care unit mechanically ventilated patients

Conditions: Infection Prophylaxis

Summary: primary objective: - to determine the pharmacokinetics (pk) of a single intravenous (iv) dose of sar279356 administered to intensive care unit (icu) patients on mechanical ventilation secondary objectives: * to determine the safety and tolerability of sar279356 * to evaluate the pharmacodynamics (pd) and immunogenicity of sar279356 * exploratory efficacy of sar279356 on prevention of bacterial infections

total study duration (from screening to last follow-up visit) is 91 days break down as follows: * screening: 1 day prior to dosing; * treatment period: one iv injection on day 1; * follow-up period: 90 days

Eligibility criteria:
inclusion criteria : * icu patients on mechanical ventilation at the time of randomization * patients or legally authorized representative (lar) giving written informed consent. exclusion criteria: * patients \<18 years of age; * documented pseudomonas infection or colonization in the last 30 days; * immunocompromised patients * hypersensitivity to the study drug and/or to prior therapy with monoclonal antibodies; * patient who has taken other investigational drugs or prohibited therapy for this study within 1 month or 5 half-lives, whichever is longer; * patient or lar who withdraws consent during the screening (starting from signed informed consent form); * acute liver injury related criteria at the time of study entry: * pregnant or breast-feeding women the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
laparoscopic surgery or robotic-assisted laparoscopic surgery in treating patients with rectal cancer that can be removed by surgery

Conditions: Recurrent Rectal Cancer; Stage I Rectal Cancer; Stage II Rectal Cancer; Stage III Rectal Cancer

Summary: rationale: robotic-assisted laparoscopic surgery may be a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. it is not yet known whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in treating patients with rectal cancer. purpose: this randomized clinical trial studies robotic-assisted laparoscopic surgery to see how well it works compared to laparoscopic surgery in treating patients with rectal cancer that can be removed by surgery.

objectives: i. to evaluate robotic-assisted rectal cancer surgery versus standard laparoscopic rectal cancer resection by means of a randomized, controlled trial. ii. to assess technical ease of the operation, as determined by the clinical indicator of low conversion rate to open operation. iii. to assess surgical accuracy and improved oncological outcome as determined by clear pathological resection margins. iv. to assess quality of life and analyze cost-effectiveness to aid evidence-based knowledge to inform nhs and other service providers and decision-makers. v. to analyze disease-free and overall survival and local recurrence rates at 3-year follow-up. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients undergo standard laparoscopic resection. arm ii: patients undergo robotic-assisted laparoscopic resection. after completion of study treatment, patients are followed up at 1 month, 6 months, and then annually thereafter for 3 years.

Eligibility criteria:
inclusion * able to provide written informed consent * diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection (i.e. staged t1-3, n0-2, m0 by ct and mri or transrectal ultrasound) * rectal cancer suitable for resection by either standard or robotic-assisted laparoscopic procedure * fit for robotic-assisted or standard laparoscopic rectal resection * asa =\< 3 * capable of completing required questionnaires at time of consent exclusion * benign lesions of the rectum * cancers of the anal canal * locally advanced cancers not amenable to curative surgery * locally advanced cancers requiring en bloc multi-visceral resection * synchronous colorectal tumours requiring multi-segment surgical resection * co-existent inflammatory bowel disease * clinical or radiological evidence of metastatic spread * concurrent or previous diagnosis of invasive cancer within 5 years that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer treated with curative intent are acceptable; for other cases please discuss with chief investigator via ctru) * history of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements * pregnancy * participation in another rectal cancer clinical trial relating to surgical technique
high dose simplified folfiri in advanced colorectal cancer: a multicentre phase ii study

Conditions: Advanced Colorectal Cancer

Summary: a multicentre phase ii study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven adenocarcinoma of the colon or rectum * documented progressive metastatic disease * patients who have at least one uni-dimensional measurable lesion by ct-scan or mri according to response evaluation criteria in solid tumours (recist) * who performance status of 0 or 1 * adequate laboratory values of haematology, liverfunction and renal function * no previous chemotherapy for metastatic colorectal cancer exclusion criteria: * past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated cancer free of disease for more than 10 years. * bowel obstruction or sub-obstruction. crohn's disease, or ulcerative colitis. * other severe illness or medical condition such as unstable cardiac disease under treatment, myocardial infarction within 6 months before inclusion. * active uncontrolled infection * other concomitant anticancer agent
effect of s-adenosylmethionine (same) on blood levels of homocysteine

Conditions: Hyperhomocysteinemia

Summary: the purpose of this study is to investigate whether s-adenosylmethionine (same), a natural substance available as a nutritional supplement, can influence blood levels of homocysteine (hcy). more specifically, we will determine if chronic oral same administration affects homocysteine metabolism in patients with vascular disease who have mild to moderate hyperhomocysteinemia.

the purpose of this study is to investigate whether s-adenosylmethionine (same), a natural substance available as a nutritional supplement, can influence blood levels of homocysteine (hcy). more specifically, we will determine if chronic oral same administration effects homocysteine metabolism in patients with vascular disease who have mild to moderate hyperhomocysteinemia through the following specific aims: specific aim 1 - to determine the effect of oral same (1200 mg/day) on plasma total homocysteine levels in subjects with mild to moderate hyperhomocysteinemia. specific aim 2 - to determine the effect of oral same (1200 mg/day) with and without supplementation of folate, vitamin b12 and b6, on plasma homocysteine levels in patients with mild to moderate hyperhomocysteinemia. specific aim 3 - to determine the effect of oral same (1200 mg/day) on plasma levels pf asymmetric dimethylarginine (adma) in subjects with mild to moderate hyperhomocysteinemia.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * must have a serum homocysteine value greater than or equal to 14 μmol/l * stable weight 3 months prior to study participation exclusion criteria: * subjects with a bmi greater than 35 or less than 18 * currently taking b 100 or other high-dose b vitamin supplements within the past 12 months * taken methionine or same supplements within the past 3 months

Keywords: hyperhomocysteinemia homocysteine s-adenosylmethionine same asymmetric dimethylagrinine (adma)
oxytocin and incitement to use olfactory stimuli in restrictive anorexia nervosa

Conditions: Anorexia

Summary: this prospective pilot study will compare adolescents with restrictive anorexia nervosa who participated for 3 months at olfactory workshops, patients who did not, and healthy patients.the groups will be evaluated before the workshops and after three months, with the wanting score after olfactory stimuli and with serum oxytocin level.

the restrictive anorexia nervosa (an) in adolescents is an eating disorder with decreased desire to eat (wanting) following olfactory stimulation. oxytocin is an hormone involved in the neuromodulation of eating behavior, but also involved in olfactory perception in schizophrenia patients, and in social cognition in patients with autism. its plasma level was found low in anorexic patients compared to control subjects. because of the similarity in disorders of social cognition between these three diseases, we assume that the desire to eat evoked by olfactory perception varies with the plasma oxytocin levels. with a prospective pilot study we will compare patients with an who participated for 3 months at olfactory workshops, an patients who did not, and healthy patients. the groups will be evaluated before the workshops and after three months, with the wanting score after olfactory stimuli and with serum oxytocin level. one application of this study will be the use of ocytocyne nasal spray to increase the eating desire and to allow weight regain

Eligibility criteria:
inclusion criteria: * medical-review * female or male -sexe, * 11 to 18 years * anorexia nervosa diagnosed according to the criteria dsm v * outpatient care or hospitalization * be able to answer the clinicals evaluations questionnaires * affiliated to social security * consentement of the legal representative and the patient exclusion criteria: * somatic comorbidity associated with diabetes, celiac disease, brain tumor * intolerance odors, predisposed to develop asthma and / or respiratory allergies pathologie chronic rhino-sinus * hyposmiques or anosmic * patients not of an inclusion criteria